US7867061B2 - Texturizing surfaces - Google Patents

Texturizing surfaces Download PDF

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Publication number
US7867061B2
US7867061B2 US11/533,528 US53352806A US7867061B2 US 7867061 B2 US7867061 B2 US 7867061B2 US 53352806 A US53352806 A US 53352806A US 7867061 B2 US7867061 B2 US 7867061B2
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United States
Prior art keywords
implant
dry ice
minutes
mandrel
ice particles
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Expired - Fee Related, expires
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US11/533,528
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US20080071371A1 (en
Inventor
Robert Elshout
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Mentor Worldwide LLC
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Mentor Worldwide LLC
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Application filed by Mentor Worldwide LLC filed Critical Mentor Worldwide LLC
Priority to US11/533,528 priority Critical patent/US7867061B2/en
Assigned to MENTOR CORPORATION reassignment MENTOR CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ELSHOUT, ROBERT
Priority to ES07018210T priority patent/ES2386201T3/es
Priority to EP07018210A priority patent/EP1902688B1/en
Priority to PL07018210T priority patent/PL1902688T3/pl
Priority to AT07018210T priority patent/ATE554730T1/de
Priority to BRPI0705754A priority patent/BRPI0705754B8/pt
Priority to CN2007101929689A priority patent/CN101195049B/zh
Publication of US20080071371A1 publication Critical patent/US20080071371A1/en
Assigned to MENTOR WORLDWIDE LLC reassignment MENTOR WORLDWIDE LLC CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: MENTOR CORPORATION
Priority to US12/957,333 priority patent/US8419507B2/en
Publication of US7867061B2 publication Critical patent/US7867061B2/en
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B24—GRINDING; POLISHING
    • B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
    • B24C1/00—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods
    • B24C1/003—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods using material which dissolves or changes phase after the treatment, e.g. ice, CO2
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/12—Mammary prostheses and implants

Definitions

  • This document relates to methods and materials involved in applying a surface texture to devices such as bodily implants (e.g., breast implants).
  • bodily implants e.g., breast implants
  • a capsule of scar tissue can form around an implant after it is placed in the body. This is a natural reaction of the body to protect itself from the introduction of a foreign object. The formation of this scar capsule is referred to as capsular contracture. Capsular contracture that may result after breast augmentation surgery can result in hardening of the breasts, which may be painful and can require additional surgery.
  • Textured implants can reduce the chance of capsular contracture.
  • the textured surface of these implants can promote tissue adherence to the implant, decreasing the amount of scar tissue that grows.
  • tissue adherence to an implant can help maintain proper implant positioning and prevent movement of the implant within the breast.
  • current methods for applying texture to an implant can be labor intensive and expensive.
  • current methods can include forming an implant shell on a mandrel, removing the shell from the mandrel, placing the shell on a second mandrel or other form, and then applying the surface texture.
  • the hole left in the shell by the first mandrel may be expanded during placement on the second mandrel or other form, resulting in shells having holes of different sizes and shapes that cannot be patched in an automated manner.
  • This document provides methods and materials related to texturizing the outer surface of implant devices, as well as devices texturized by the methods provided herein.
  • the methods provided herein include contacting the outer surface of a device with solid carbon dioxide (CO 2 ), otherwise known as dry ice.
  • CO 2 solid carbon dioxide
  • the physical collision of dry ice pellets with the outer surface of an implant, as well as the temperature difference between the dry ice and the implant, can create dimples in the outer surface of the implant and cause the dry ice to evaporate.
  • These methods can be advantageous in that they can permit texture to be applied to the entire surface of an implant, and can be used to make implants from a single material, thus obviating the stress that can result between layers when different types of materials are used.
  • These methods also can be economical from both monetary and material standpoints, and can be automated. In addition, these methods can result in a patch hole of standardized size, thus allowing for automation of the patching process.
  • this document features a method for texturizing a bodily implant having an outer surface.
  • the method can include contacting the outer surface of the bodily implant with dry ice particles.
  • the bodily implant can be a breast implant.
  • the dry ice particles can have a maximum diameter of about 1 mm to about 1.5 mm.
  • the dry ice particles can be passed through a screen prior to contacting the outer surface of the bodily implant.
  • the screen can define openings having a maximum width of about 1 mm to about 2 mm.
  • the bodily implant can have an inner cured layer of an elastomer and an outer uncured layer of the elastomer in a solvent, wherein the method comprises contacting the outer uncured layer with the dry ice particles.
  • the outer uncured layer can comprise from about 10 percent to about 30 percent solids.
  • the outer uncured layer can have a devolatilization time of about 8 minutes to about 10 minutes.
  • the dry ice particles can be directed at the outer surface of the bodily implant by a stream of air at a pressure of about 5 bar.
  • this document features a bodily implant having an outer surface with a surface texture applied by contacting the outer surface with dry ice particles.
  • the bodily implant can be a breast implant.
  • the dry ice particles can have a maximum diameter of about 1 mm to about 1.5 mm.
  • the dry ice particles can have been passed through a screen prior to contacting the outer surface of the bodily implant.
  • the screen can define openings having a maximum width of about 1 mm to about 2 mm.
  • the surface area can have been applied by coating the bodily implant with an outer uncured layer of an elastomer in a solvent (e.g., an outer uncured layer comprising from about 10 percent to about 30 percent solids, having a devolatilization time of about 8 minutes to about 10 minutes, or both), and contacting the outer uncured layer with the dry ice particles.
  • a solvent e.g., an outer uncured layer comprising from about 10 percent to about 30 percent solids, having a devolatilization time of about 8 minutes to about 10 minutes, or both
  • the dry ice particles can have been directed at the outer surface of the bodily implant by a stream of air at a pressure of about 5 bar.
  • FIG. 1 is a depiction of the outer shell of a breast implant on a mandrel as it is contacted by dry ice particles ejected from a nozzle.
  • Elastomeric articles such as shells for bodily implants (e.g., breast implants) can be made using a mandrel having a mold in the desired form connected to a shaft.
  • the mold can be repeatedly dipped in or coated with an elastomeric compound (e.g., polyurethane, BioflexTM, silicone, or latex) dispersed in a solvent (e.g., xylene, heptane, tetrahudrofurane/dioxin, N,N-dimethylformamide, N,N-dimethylacetamide, naptha, or water).
  • a solvent e.g., xylene, heptane, tetrahudrofurane/dioxin, N,N-dimethylformamide, N,N-dimethylacetamide, naptha, or water.
  • the mandrel can be heated to allow the solvent to evaporate.
  • the mandrel also can be heated
  • the methods provided herein can be used to texturize the exterior surface of such bodily implants. These methods include contacting the exterior surface of an implant with dry ice pellets, which can create imprints on the surface of the device and then evaporate.
  • the shell of a breast implant can be formed on a mandrel by covering the mandrel with an elastomer (e.g., silicone). The shell may be cured, or the shell may not be cured. In some cases, the shell can be cured, and then a further layer of polymer can be applied and not cured. While still on the mandrel (e.g., during evaporation of solvent), the shell can be contacted (e.g., blasted) with pellets of dry ice.
  • an elastomer e.g., silicone
  • Dry ice is inert, and is available in medical grade.
  • the pellets can be directed at one or more particular areas of the shell, or can be directed at the entire surface of the shell. Because the shell can be texturized while still on the mandrel, rather than being removed from the mandrel and then placed on another device for texturizing, the hole in the shell from the mandrel stem can have the same or similar dimensions as holes in other implant shells generated using the same method. In other words, shell manufacture can be standardized to allow for automated patching of the shells.
  • any suitable device can be used to contact an implant with dry ice (e.g., dry ice pellets).
  • dry ice pellets e.g., dry ice pellets
  • a commercially available system such as a CryoClean system from Hoek Loos (Schiedam, Holland) can be used.
  • Such a system can, for example, use compressed air to propel particles of dry ice at high velocity, thus achieving an impact energy sufficient to create imprints on surfaces.
  • Dry ice pellets can be pre-produced, or can be produced on demand from liquid CO 2 . When dry ice pellets impact, they can compress and mushroom out into a high velocity “snow,” and then can instantly sublimate back into their natural state as a gas, leaving no residue. This can create a compression tension wave.
  • the CO 2 gas can expand to nearly 800 times the volume of the pellet in milliseconds, resulting in a small series of micro-explosions at the impact point.
  • a system such as a CryoClean system can be equipped with any suitable mechanism for achieving dry ice pellets of a size appropriate to give a desired surface texture to an implant.
  • dry ice pellets can be passed from a holding tank through a hose, and out a nozzle aimed at an implant.
  • the nozzle can contain a means for reducing the size of the pellets.
  • a screen e.g., a wire mesh screen
  • more than one (e.g., two, three, four, or five) screens can be positioned within the nozzle of a device, such that the dry ice pellets must pass through all of the screens before exiting the nozzle.
  • the pellets can be broken into smaller particles of a particular maximum size.
  • the size of the dry ice pellets By controlling the size of the dry ice pellets, homogeneous texturing of the implant can be achieved.
  • a screen with larger openings can be used to produce particles of dry ice with a larger maximum size, increasing the size of the imprints made in the implant surface.
  • a screen can have openings of any shape (e.g., square, circular, oval, rectangular, triangular, or any other shape), and can contain wire of any suitable thickness.
  • a screen can include wire having a thickness of about 0.08 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, or more than 1 mm.
  • the openings in a screen can have a maximum width or diameter of, for example, about 0.2 mm to about 5 mm (e.g., about 0.3 mm, about 0.5 mm, about 0.7 mm, about 1 mm, about 1.2 mm, about 1.5 mm, about 1.7 mm, about 2 mm, about 2.3 mm, about 2.5 mm, about 2.8 mm, about 3 mm, about 3.2 mm, about 3.5 mm, about 3.7 mm, about 4 mm, about 4.5 mm, or about 5 mm).
  • a screen having openings with a maximum width or diameter of about 1 mm to about 3 mm for example, can result in dry ice particles having a maximum width of about 1 mm to about 3 mm.
  • maximum width or “maximum diameter” with respect to an opening in a screen refers to the longest straight line distance that can be measured between two points on the perimeter of the opening.
  • maximum width or “maximum diameter” with respect to a dry ice pellet refers to the longest straight line distance that can be measured through the pellet between two points on the exterior surface of the pellet.
  • the percent solids (viscosity) of the substance applied as the outer layer of an implant shell can be adjusted.
  • the percent solids can be, for example, from about 0% to about 50%, about 2.5% to about 40%, about 5% to about 35%, about 10% to about 35%, or about 15% to about 25%.
  • a higher viscosity, particularly at a consistent devolatilization time can result in a coarser texture, for example, upon dry ice blasting.
  • Devolatilization time also can be adjusted to control the surface texture. During evaporation of the solvent, the viscosity of the outer layer of the implant can rise.
  • devolatilization time can be an important parameter for controlling the structure of the surface texture.
  • the devolatilization time can be, for example, from about 1 minute to about 20 minutes (e.g., about 2 minutes to about 6 minutes, about 5 minutes to about 13 minutes, about 6 minutes to about 8 minutes, about 7 minutes to about 12 minutes, about 8 minutes to about 10 minutes, about 10 minutes to about 15 minutes, or about 15 minutes to about 20 minutes).
  • the air pressure of the application system e.g., the CryoClean system
  • a higher air pressure can result in greater velocity of the dry ice particles at impact with the implant surface, which can affect the resulting structure of the surface texture.
  • the air pressure can be, for example, from about 2 bar to about 10 bar (e.g., about 2 bar, about 3 bar, about 4 bar, about 5 bar, about 6 bar, about 7 bar, about 8 bar, about 9 bar, or about 10 bar). Any or all of the parameters described herein can be adjusted to, for example, control the depth and or pattern of the surface texture.
  • the methods provided herein can include moving the mandrel holding the implant or moving the device used to direct the dry ice particles at the implant.
  • a mandrel can be inverted, moved back and forth, or rotated during a texturizing procedure, or the nozzle of the device used to direct the dry ice particles can be moved around the mandrel, or up and down or back and forth with respect to the mandrel as it directs dry ice particles toward the implant.
  • both the mandrel and the nozzle can be moved during a texturizing procedure.
  • Such movement can, for example, facilitate production of a homogenous surface texture over the entire outer surface of an implant shell.
  • the movement can be simultaneous with surface texture generation.
  • surface texture can be generated on one portion of an implant, the dry ice flow can be stopped, the mandrel and/or the nozzle can be moved, and the flow of dry ice particles can be resumed such that surface texture is generated on another portion of the implant.
  • FIG. 1 is a depiction of one embodiment of a texturizing procedure as provided herein.
  • Mandrel 10 can include stem 20 and mold 30 , with mold 30 covered by implant shell 40 .
  • Nozzle 50 can direct dry ice particles 60 toward the surface of implant shell 40 .
  • mandrel 10 can be rotated (e.g., in the direction of the arrow) as implant shell 40 is contacted by dry ice particles 60 .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Mechanical Engineering (AREA)
  • Prostheses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Diaphragms For Electromechanical Transducers (AREA)
US11/533,528 2006-09-20 2006-09-20 Texturizing surfaces Expired - Fee Related US7867061B2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
US11/533,528 US7867061B2 (en) 2006-09-20 2006-09-20 Texturizing surfaces
ES07018210T ES2386201T3 (es) 2006-09-20 2007-09-17 Superficies texturizantes
EP07018210A EP1902688B1 (en) 2006-09-20 2007-09-17 Texturizing surfaces
PL07018210T PL1902688T3 (pl) 2006-09-20 2007-09-17 Teksturowanie powierzchni
AT07018210T ATE554730T1 (de) 2006-09-20 2007-09-17 Oberflächentexturierung
CN2007101929689A CN101195049B (zh) 2006-09-20 2007-09-19 纹理化表面
BRPI0705754A BRPI0705754B8 (pt) 2006-09-20 2007-09-19 método para texturizar um implante mamário tendo uma superfície externa e implante mamário
US12/957,333 US8419507B2 (en) 2006-09-20 2010-11-30 Texturizing surfaces

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US11/533,528 US7867061B2 (en) 2006-09-20 2006-09-20 Texturizing surfaces

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US12/556,398 Continuation-In-Part US20100125119A1 (en) 2002-11-04 2009-09-09 Polyamide molding material, molded articles that can be produced therefrom and the use thereof
US12/957,333 Continuation US8419507B2 (en) 2006-09-20 2010-11-30 Texturizing surfaces

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US7867061B2 true US7867061B2 (en) 2011-01-11

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EP (1) EP1902688B1 (pt)
CN (1) CN101195049B (pt)
AT (1) ATE554730T1 (pt)
BR (1) BRPI0705754B8 (pt)
ES (1) ES2386201T3 (pt)
PL (1) PL1902688T3 (pt)

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US20110070356A1 (en) * 2006-09-20 2011-03-24 Mentor Worldwide Llc Texturizing Surfaces
US20130053956A1 (en) * 2007-11-05 2013-02-28 Allergan, Inc. Soft prosthesis shell texturing method
US20140256229A1 (en) * 2013-03-11 2014-09-11 Howmedica Osteonics Corp. Method of improving bond strength of peek implants with bone cement
WO2015061035A1 (en) * 2013-10-22 2015-04-30 Tosoh Smd, Inc. Optimized textured surfaces and methods of optimizing
US9138309B2 (en) 2010-02-05 2015-09-22 Allergan, Inc. Porous materials, methods of making and uses
US9155613B2 (en) 2010-11-16 2015-10-13 Allergan, Inc. Methods for creating foam-like texture
US9205577B2 (en) 2010-02-05 2015-12-08 Allergan, Inc. Porogen compositions, methods of making and uses
US9593224B2 (en) 2010-09-28 2017-03-14 Allergan, Inc. Porogen compositions, methods of making and uses
US10092392B2 (en) 2014-05-16 2018-10-09 Allergan, Inc. Textured breast implant and methods of making same
US20180360594A1 (en) * 2012-12-13 2018-12-20 Allergan, Inc. Variable surface breast implant
US10765501B2 (en) 2008-08-13 2020-09-08 Allergan, Inc. Dual plane breast implant
US10864661B2 (en) 2012-12-13 2020-12-15 Allergan, Inc. Device and method for making a variable surface breast implant
US11202853B2 (en) 2010-05-11 2021-12-21 Allergan, Inc. Porogen compositions, methods of making and uses

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US8506627B2 (en) 2008-08-13 2013-08-13 Allergan, Inc. Soft filled prosthesis shell with discrete fixation surfaces
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US8889751B2 (en) 2010-09-28 2014-11-18 Allergan, Inc. Porous materials, methods of making and uses
US9044897B2 (en) 2010-09-28 2015-06-02 Allergan, Inc. Porous materials, methods of making and uses
US9138308B2 (en) 2010-02-03 2015-09-22 Apollo Endosurgery, Inc. Mucosal tissue adhesion via textured surface
US20110196488A1 (en) * 2010-02-03 2011-08-11 Allergan, Inc. Degradation resistant implantable materials and methods
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EP2563851A1 (en) 2010-04-27 2013-03-06 Allergan, Inc. Foam-like materials and methods for producing same
CA2799201C (en) 2010-05-11 2016-09-20 Allergan, Inc. Porogen compositions, methods of making and uses
US20120100266A1 (en) 2010-10-20 2012-04-26 Pepsico., Inc. Control of bubble size in a carbonated liquid
US8546458B2 (en) 2010-12-07 2013-10-01 Allergan, Inc. Process for texturing materials
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CA2949231A1 (en) 2014-05-16 2015-11-19 Allergan, Inc. Soft filled prosthesis shell with variable texture
CN105997302A (zh) * 2016-07-18 2016-10-12 青岛三帝生物科技有限公司 基于3d打印的防包膜挛缩乳房假体制作方法和乳房假体
CN107309809A (zh) * 2017-06-01 2017-11-03 成都贝施美生物科技有限公司 一种新型喷砂装置
CN107160292A (zh) * 2017-06-01 2017-09-15 成都贝施美生物科技有限公司 种植体外表面喷砂设备
CN113144389B (zh) * 2021-03-16 2022-06-14 科塞尔医疗科技（苏州）有限公司 双层喷砂球囊，其制备方法以及多层喷砂球囊

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US20080071371A1 (en) 2008-03-20
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ATE554730T1 (de) 2012-05-15
EP1902688B1 (en) 2012-04-25
US8419507B2 (en) 2013-04-16
EP1902688A1 (en) 2008-03-26
BRPI0705754B8 (pt) 2021-06-22
US20110070356A1 (en) 2011-03-24
PL1902688T3 (pl) 2012-09-28
ES2386201T3 (es) 2012-08-13
BRPI0705754B1 (pt) 2019-12-31
BRPI0705754A2 (pt) 2008-11-25

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